NOGO for an Overactive Bladder
- Conditions
- Overactive BladderNocturia
- Interventions
- Drug: extract from Angelica archangelica leafDrug: Placebo
- Registration Number
- NCT04357223
- Lead Sponsor
- SagaNatura
- Brief Summary
This is a double-blind, randomized and placebo-controlled study to evaluate the safety and effectiveness of NoGo, a standardized extract from Angelica archangelica, on overactive bladder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Suspected or diagnosed with overactive bladder (average ≥ of 1.5 nocturnal voids per night and/or less then 2 hours between voids at least half time of the day (question 2 IPSS)
- High alcohol consumption (males > 3 beers/day (36 g alcohol), females >2 beers/day --
- (24 g alcohol), but we take weekly average.
- Abnormal urinary findings suggestive of urinary tract infection, significant hematuria or glucosuria requiring further evaluation.
- Chronic incontinence.
- Recurrent urinary tract infections (3 or more times per year).
- Pregnancy, lactation, last child born at least one year before, uterine prolapse, histerectomy
- Surgical treatment for bladder outlet obstruction/BPH performed within the past 6 months. Moderate to severe prostate hyperplasia (IPSS questionnaire).
- Medical history or active conditions which, in the opinion of the principal investigator (PI) and physicians participating in the study would prohibit participation in the study. This includes, but is not limited to: diabetes, cancer, renal failure, cirrhosis or chronic liver disease, pancreatic diseases, recent (<6 months) myocardial infarction or unstable coronary artery disease.
- Psychiatric diseases and medication.
- Use of NoGO or other products containing A. archangelica extract within the previous 2 months prior to randomisation.
- Known allergy to compound or any other ingredients of NoGo.
- Supplements like pumpkin seeds, natural products with diuretic effect. Not exclusion if they have a wash out period.
- Receipt of an investigational product within 30 days prior to enrolment or expected receipt during this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental extract from Angelica archangelica leaf - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Reduction of urination frequency (number of voids per 24 hours) 6 weeks Reduction in number of voids per 24 hours as assessed by a 3 day voiding diary before and after treatment
- Secondary Outcome Measures
Name Time Method Reduced number of daytime voids 6 weeks Reduction in number of voids occurring during waking hours as assessed by a 3 day voiding diary before and after treatment
Reduced number of nocturnal voids (nocturia) 6 weeks Reduction in number of voids occurring during sleeping hours as assessed by a 3 day voiding diary before and after treatment
Reduced number of nocturnal voids (nocturia) per hour sleeping time 6 weeks Reduction in number of voids occurring during sleeping hours corrected by sleeping time as assessed by a 3 day voiding diary before and after treatment
Reduced number of voids occurring shortly after the last one 6 weeks Reduction in number of voids occurring shortly after the preceding void (less than 60, 90 and 120 minutes) as assessed by a 3 day voiding diary before and after treatment
Improvement of the results of the International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB) 6 weeks Questionnaire assessing overactive bladder. Overall score is 0-16 with greater values indicating increased symptom severity
Improvement of the results of the The International Prostate Symptom Score (IPSS) 6 weeks A questionnaire assessing prostate symptoms. Overall score is 0-35 (7 questions with score 0-5 each), with greater values indicating increased symptom severity
Trial Locations
- Locations (1)
Universidad Politecnica de Madrid
🇪🇸Madrid, Spain